Phase 2 Trial of HY209gel in Atopic Dermatitis Patients

NCT ID: NCT06024499

Last Updated: 2024-04-26

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE2
• Total Enrollment: 210 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-03-01
• Study Completion Date: 2026-03-31

Brief Summary

This is a randomized, double-blind, placebo-controlled, multi-center, phase 2 study in patients with mild to moderate Atopic Dermatitis(AD), which consists of 2 parts.

Detailed Description

Part 1 (2 cohorts): Total 33 subjects

• Cohort A: 15 subjects (6 HY209gel 0.5%, 6 HY209gel 1%, and 3 placebo)
• Cohort B: 9 subjects (6 HY209gel 2%, and 3 placebo)
• Cohort C: 9 subjects (6 HY209gel 4%, and 3 placebo)

Part 2 (3 treatment groups): Total 177 subjects

• Low dose of HY209gel: 59 subjects
• High dose of HY209gel: 59 subjects
• Placebo (Vehicle): 59 subjects

Part 1 is a dose-escalation part of HY209gel using lower doses of HY209gel (0.5% and 1%) with escalation (HY209gel 2% and 4%) to evaluate the pharmacokinetics(PK), safety, and tolerability of HY209gel treatment. Escalation to the next dose level will be decided by the Safety Monitoring Committee(SMC) that will review all available safety data of the planned dose level within the timeline specified on SMC charter after all enrolled subjects of each cohort complete 2-week treatment and determine the escalation to the next dose to be safe.

Based on the interim analysis for 4-week safety and efficacy data collected from Part 1, two doses will be selected for use in Part 2, which will enroll up to 177 subjects in 3 treatment arms (59 subjects per treatment arm) to evaluate the efficacy and safety of HY209gel, compared to placebo (vehicle) for 8-week treatment period.

Conditions

Atopic Dermatitis; Atopic Dermatitis Eczema; Atopic Dermatitis of Scalp

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

PART 2 High-Dose

Active group selected for PART1 as a high-dose

Group Type: ACTIVE_COMPARATOR

HY209GEL Active

Intervention Type: DRUG

Selected two among four doses (HY209GEL 0.5% or 1% or 2% or 4%) in PART1

PART 2 Low-Dose

Active group selected for PART1 as a Low-dose

Group Type: ACTIVE_COMPARATOR

HY209GEL Active

Intervention Type: DRUG

Selected two among four doses (HY209GEL 0.5% or 1% or 2% or 4%) in PART1

PART 2 Placebo

Placebo group

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: OTHER

Placebo

Interventions

HY209GEL Active

Selected two among four doses (HY209GEL 0.5% or 1% or 2% or 4%) in PART1

Intervention Type: DRUG

Placebo

Placebo

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• Male or female subjects aged 18 or older
• Subjects who have a history of AD at least 6 months ago from screening and have been clinically stable for ≥ 1 month
• Subjects with a clinical diagnosis of AD according to the Hanifin and Rajka Criteria by a board certified/eligible dermatologist
• Subjects who have a minimum of 5% and a maximum of 30% of total body surface area (BSA) affected by AD at screening and baseline visits
• Subjects with vIGA score 2 or 3 corresponding to mild to moderate AD at screening and baseline visit
• Subjects should be a literate person who can read the participant information sheet and consent form/questionnaire and understand the language of the participation

Exclusion Criteria

• Subjects who have unstable AD (i.e., remaining clinical stable less than 6 months) or any consistent requirement for any potency topical corticosteroids
• Subjects who have topical treatment with corticosteroids within 2 weeks prior to baseline visit or other topical treatments of the AD area at screening (moisturizers/emollients are allowed)
• Subjects who had systemic treatment with corticosteroids or cyclosporine or other immunosuppressive treatments within 4 weeks prior to baseline visit
• Subjects who had dupilumab or any other biologics within 6 months prior to baseline visit
• Subjects who take any systemic anti-infective or antibiotic treatments within 1 week prior to baseline visit
• Subjects who had ultraviolet irradiation (including photopheresis) within 4 weeks prior to screening
• Subjects who have active malignancy or history of cancer in 5 years prior to screening, except for treated cautions basal cell carcinoma and in situ cervical cancer
• Subjects who have any other skin diseases that would affect the ability to assess the AD
• Subjects who are taking strong CYP3A4 inhibitor or any other concomitant drug that, in the opinion of the PI, may cause interference with the treatment
• Subjects who participated in another drug or device trial within 4 weeks prior to screening...etc

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 100 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Shaperon

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Cahaba Dermatology Skin Health Center

Birmingham, Alabama, United States

Site Status: RECRUITING

RAOOF MD Dermatology

Encino, California, United States

Site Status: RECRUITING

Continental Clinical Solutions, LLC

Towson, Maryland, United States

Site Status: RECRUITING

Sadick Dermatology

New York, New York, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Shaperon Shaperon

Role: CONTACT

seoh@shaperon.com

82-2-6083-8315

Shaperon Shaperon

Role: CONTACT

Facility Contacts

Dr. Groysman

Role: primary

Dr. Raoof

Role: primary

Dr. Mardiney

Role: primary

Dr. Sadick

Role: primary

Other Identifiers

HY209-AD-02

Identifier Type: -

Identifier Source: org_study_id